FDA Wants Resource Planning In Corrective Action Plans

According to the The QA Pharm blog,

"The most successful corrective action plans have been those where the direct responsible individuals are named and appear in detailed project plans. There is a clear picture of what success looks like and how to get there. But most of all, the resources are identified to execute the work."

Apparently in an FDA Warning Letter to Teva early this year,  the FDA is telegraphing their desire to see these kinds of elements in a response:

• a plan
• what kind of data will be collected to measure the effectiveness of the plan
• a timeline for the plan
• the identification of resources allocated to address the issue

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

If you are looking for live, onsite, in-person delivered courses or classes, then consider the following popular courses:

Our most popular course

Put fun back into GMP training!

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors

CAPA Basics - Carl Anderson and Barbara Immel

• FDA GMP QSR cGMP Training - online training courses by SkillsPlus International Inc.

I always enjoy running across well-written GXP articles.  Kudos to Carl for posting this informative CAPA Basics article by Barbara Immel on his blog (GXP Perspectives), CAPA Basics- Corrective And Preventative Action.

I've been following Barbara Immel's writing for some time, and always pick up several pearls of wisdom from her.

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

You might also be interested in:

Root Cause Analysis & Deviation Investigation Report Writing - An online self-study course - FDA, cGMP, QSR, GMP Training

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog

FDA Offers Warning Letter Close-Out Letter Program

According to the FDA's announcement, Warning Letter Close-Out Letter Program, the FDA may issue a Warning Letter close-out letter ("close-out letter") once the Agency has completed an evaluation of corrective actions undertaken by a firm in response to a Warning Letter. A close-out letter may issue when, based on FDA’s evaluation, the firm has taken corrective action to address the violations contained in the Warning Letter. This procedure applies to Warning Letters issued on or after September 1, 2009. 

Return Home: http://drughealth.blogspot.com/